Events

Recall of GE Proteus XR/a X-Ray system

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by GE Hualun Medical Systems Co Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    18096
  • Event Initiated Date
    2015-02-12
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Reason
    Ge healthcare has recently become aware of a potential safety issue involving the breakage of the steel cable which supports the bucky device in certain wall stands of proteus xr/a x-ray imaging systems. a fall of a bucky while the system is in use could result in an injury to a patient or operator. there have been no injuries reported as a result of this issue.
  • Action
    Product to be modified

Device

GE Proteus XR/a X-Ray system

Manufacturer

GE Hualun Medical Systems Co Ltd